Step 1 Review Safety Data

The first step is to review your organization s safety data, both the statistics and the actual incident reports. The incident data will help you understand whether the company has a significant safety problem and will be useful in planning how you will sell the importance of the proposed improvement efforts. Find out whether your organization is above or below the industry average. If your safety department does not have data about your industry, OSHA, the National Labor Board, or industry associations can usually provide such data. 

The safety data should also help you identify groups with the highest and lowest incidence rates. Conduct the bulk of your interviews and observations with these groups to learn what factors account for their current levels of safety performance. 

Review safety reports that summarize incident data a) The rate of recordable injuries for the site or organization b) Areas with hi injury rates a) Compare with industry average to assess relative safety performance b) Interview personnel in hi -risk areas 

Review individual accident reports Tasks and equipment involved in injuries a) Prepare questions to ask about hi -risk jobs during interviews b) Begin identifying specific tasks to include in the observation process 

Collect data on compensation costs and, if possible, costs of property damage from accidents Calculate an average cost per incident Estimate cost savings that may result from reduced accident rates 

---

After an introduction that considers the place of chemical industry in society, the basic concepts related to risk analysis are presented. The second section reviews the steps of the risk analysis of chemical processes discussed. Safety data are presented in the third section and the methods of hazard identification in the section after that. The chapter closes with a section devoted to the practice of risk analysis. 

The first step to determine whether a dye is hazardous is the appropriate evaluation or testing of the acute toxicity of dyes, as defined by the EU Directive 67/ 548/EEC (with numerous amendments). A comprehensive review on such data including skin and eye irritation of numerous commercial dyes, derived from Safety Data Sheets, showed that the potential for these acute toxic effects ( harmful or toxic ) was very low. Although the review stems from an early date, it can be asumed that the results are still valid today [5],... 

Review all data obtained from the driving and previous employer investigations, and the PSP, as soon as it is received (this may occur before an interview can be arranged). If no disqualiflers are discovered, proceed to step five. It is also a best practice to have a third party (such as another person in the safety department or operations department) review the applicant s file, to make sure that nothing was missed. 

Step 1. Review the organization s safety data, including injury statistics and actual accident reports. Determine if the organization is above or below industry average. Identify groups of workers with the highest and lowest incidence rates. 

The MPIs should be dated and updated in a controlled manner. The MPIs should also include the appropriate materials safety data sheets (MSDSs) for the materials being used. In many cases the MPIs should be reviewed with the R D staff that have been involved in writing the specifications to ensure that mistakes are not made. The R D staff should be included in process review meetings for the same reason (see Appendix A). In some cases, MPIs and specifications must be written from an existing process. Care must be taken that the operators reveal all of the important steps and parameters to the person documenting the process. 

Step 1.6 Review Documentation. Collate and review all existing documentation and information regarding the process. Regional or plant surveys may have been undertaken, environmental audits may have been conducted, safety audit findings may be available these could yield useful information indicating the areas for concern, and will show gaps where no data are available. 

It is not unusual to have several inherent safety reviews during the product/process development effort. Early reviews will often not have all of the information required for Steps 1 to 9. The follow-up items will describe what is necessary to obtain the missing information such as toxicity data on new intermediates or products of undesired reactions. 

In this study detailed fault trees with probability and failure rate calculations were generated for the events (1) Fatality due to Explosion, Fire, Toxic Release or Asphyxiation at the Process Development Unit (PDU) Coal Gasification Process and (2) Loss of Availability of the PDU. The fault trees for the PDU were synthesized by Design Sciences, Inc., and then subjected to multiple reviews by Combustion Engineering. The steps involved in hazard identification and evaluation, fault tree generation, probability assessment, and design alteration are presented in the main body of this report. The fault trees, cut sets, failure rate data and unavailability calculations are included as attachments to this report. Although both safety and reliability trees have been constructed for the PDU, the verification and analysis of these trees were not completed as a result of the curtailment of the demonstration plant project. Certain items not completed for the PDU risk and reliability assessment are listed. 

The most critical decision to be made is the choice of the best solvent to facilitate extraction of the drug residue while minimizing interference. A review of available solubility, logP, and pK /pKb data for the marker residue can become an important first step in the selection of the best extraction solvents to try. A selected list of solvents from the literature methods include individual solvents (n-hexane, " dichloromethane, ethyl acetate, acetone, acetonitrile, methanol, and water ) mixtures of solvents (dichloromethane-methanol-acetic acid, isooctane-ethyl acetate, methanol-water, and acetonitrile-water ), and aqueous buffer solutions (phosphate and sodium sulfate ). Hexane is a very nonpolar solvent and could be chosen as an extraction solvent if the analyte is also very nonpolar. For example, Serrano et al used n-hexane to extract the very nonpolar polychlorinated biphenyls (PCBs) from fat, liver, and kidney of whale. One advantage of using n-hexane as an extraction solvent for fat tissue is that the fat itself will be completely dissolved, but this will necessitate an additional cleanup step to remove the substantial fat matrix. The choice of chlorinated hydrocarbons such as methylene chloride, chloroform, and carbon tetrachloride should be avoided owing to safety and environmental concerns with these solvents. Diethyl ether and ethyl acetate are other relatively nonpolar solvents that are appropriate for extraction of nonpolar analytes. Diethyl ether or ethyl acetate may also be combined with hexane (or other hydrocarbon solvent) to create an extraction solvent that has a polarity intermediate between the two solvents. For example, Gerhardt et a/. used a combination of isooctane and ethyl acetate for the extraction of several ionophores from various animal tissues. 

The next step is to calculate a reference dose (RfD) by dividing the NOAEL by the safety or uncertainty factors appropriate for the pesticide under review. Additional safety factors can be used for severity of the toxicological effect, if sensitive sub-populations such as children are likely to be exposed to the pesticide and if there are scientific uncertainties in the data. This approach is used for establishing the risk from exposure to threshold chemicals. 

Before a new product gains approval to be marketed in the United States, two major steps must be taken. One is the technical or scientific review, in which reviewers from the U.S. Food and Drug Administration (FDA), and sometimes an outside advisory committee of experts, review the scientific and clinical data to determine the product s safety and efficacy. As part of that review, an FDA investigator is sent... 

These identified AE-drug combinations are hypotheses for further testing follow-up may be necessary to determine whether they represent a potential drug safety issue. Further evaluation may include a query and review of the company s safety database, review of the scientific literature and preclinical data and consultation/discussion with internal and external experts. If a product safety issue was identified, next steps would include the development of a risk management and risk communication plan. 

The European - United States Paediatric Formulation Initiative (Eu-US PEI) has established that there is a pressing need for a single authoritative comprehensive database of adverse effects of excipients for paediatrics. Safety and Toxicity of Excipients for Paediatrics (STEP) Database holds all the animal toxicity and human health data, regulatory information and toxicological reviews of excipients. STEP acts as repository for all the scientific communities to share the data for better understanding and paediatric medicines development (European Paediatric Eormu-lation Initiative. STEP Database. See [3]). 

---